The Precision Interventions for Severe and/or Exacerbation-Prone (PrecISE) Asthma Network: An overview of Network organization, procedures, and interventions.
Severe asthma
adaptive clinical trial design
asthma exacerbation
biomarker
non–type 2 asthma
patient advisory committee
precision medicine
type 2 asthma
Journal
The Journal of allergy and clinical immunology
ISSN: 1097-6825
Titre abrégé: J Allergy Clin Immunol
Pays: United States
ID NLM: 1275002
Informations de publication
Date de publication:
02 2022
02 2022
Historique:
received:
20
05
2021
revised:
24
09
2021
accepted:
07
10
2021
pubmed:
2
12
2021
medline:
4
3
2022
entrez:
1
12
2021
Statut:
ppublish
Résumé
Asthma is a heterogeneous disease, with multiple underlying inflammatory pathways and structural airway abnormalities that impact disease persistence and severity. Recent progress has been made in developing targeted asthma therapeutics, especially for subjects with eosinophilic asthma. However, there is an unmet need for new approaches to treat patients with severe and exacerbation-prone asthma, who contribute disproportionately to disease burden. Extensive deep phenotyping has revealed the heterogeneous nature of severe asthma and identified distinct disease subtypes. A current challenge in the field is to translate new and emerging knowledge about different pathobiologic mechanisms in asthma into patient-specific therapies, with the ultimate goal of modifying the natural history of disease. Here, we describe the Precision Interventions for Severe and/or Exacerbation-Prone Asthma (PrecISE) Network, a groundbreaking collaborative effort of asthma researchers and biostatisticians from around the United States. The PrecISE Network was designed to conduct phase II/proof-of-concept clinical trials of precision interventions in the population with severe asthma, and is supported by the National Heart, Lung, and Blood Institute of the National Institutes of Health. Using an innovative adaptive platform trial design, the PrecISE Network will evaluate up to 6 interventions simultaneously in biomarker-defined subgroups of subjects. We review the development and organizational structure of the PrecISE Network, and choice of interventions being studied. We hope that the PrecISE Network will enhance our understanding of asthma subtypes and accelerate the development of therapeutics for severe asthma.
Identifiants
pubmed: 34848210
pii: S0091-6749(21)01819-4
doi: 10.1016/j.jaci.2021.10.035
pmc: PMC8821377
mid: NIHMS1766170
pii:
doi:
Substances chimiques
Biomarkers
0
Types de publication
Journal Article
Research Support, N.I.H., Extramural
Research Support, Non-U.S. Gov't
Review
Langues
eng
Sous-ensembles de citation
IM
Pagination
488-516.e9Subventions
Organisme : NHLBI NIH HHS
ID : UG1 HL139124
Pays : United States
Organisme : NIAID NIH HHS
ID : K23 AI135094
Pays : United States
Organisme : NIAID NIH HHS
ID : K23 AI125785
Pays : United States
Organisme : NHLBI NIH HHS
ID : UG1 HL139098
Pays : United States
Organisme : NCATS NIH HHS
ID : UL1 TR001422
Pays : United States
Organisme : NIEHS NIH HHS
ID : P30 ES023513
Pays : United States
Organisme : NHLBI NIH HHS
ID : UG1 HL139119
Pays : United States
Organisme : NCATS NIH HHS
ID : UL1 TR002389
Pays : United States
Organisme : NCATS NIH HHS
ID : UL1 TR002373
Pays : United States
Organisme : NHLBI NIH HHS
ID : UG1 HL139118
Pays : United States
Organisme : NHLBI NIH HHS
ID : UG1 HL139117
Pays : United States
Organisme : NHLBI NIH HHS
ID : UG1 HL139125
Pays : United States
Organisme : NHLBI NIH HHS
ID : UG1 HL139106
Pays : United States
Organisme : NCATS NIH HHS
ID : UL1 TR000427
Pays : United States
Organisme : NHLBI NIH HHS
ID : U24 HL138998
Pays : United States
Organisme : NCATS NIH HHS
ID : UL1 TR001857
Pays : United States
Organisme : NCATS NIH HHS
ID : UL1 TR001872
Pays : United States
Organisme : NIEHS NIH HHS
ID : P30 ES005605
Pays : United States
Organisme : NCATS NIH HHS
ID : U24 TR001608
Pays : United States
Organisme : NHLBI NIH HHS
ID : UG1 HL139123
Pays : United States
Organisme : NCATS NIH HHS
ID : UL1 TR001442
Pays : United States
Organisme : NIAID NIH HHS
ID : T32 AI007512
Pays : United States
Organisme : NCATS NIH HHS
ID : UL1 TR002489
Pays : United States
Organisme : NIGMS NIH HHS
ID : U54 GM104940
Pays : United States
Organisme : NCI NIH HHS
ID : P50 CA058223
Pays : United States
Organisme : NIAID NIH HHS
ID : U01 AI097073
Pays : United States
Organisme : NHLBI NIH HHS
ID : UG1 HL139126
Pays : United States
Organisme : NHLBI NIH HHS
ID : L30 HL149106
Pays : United States
Organisme : NHLBI NIH HHS
ID : UG1 HL139054
Pays : United States
Organisme : NCATS NIH HHS
ID : UL1 TR002366
Pays : United States
Organisme : NHLBI NIH HHS
ID : T32 HL007563
Pays : United States
Investigateurs
Dean Billheimer
(D)
Eugene R Bleecker
(ER)
Emily Branch
(E)
Michelle Conway
(M)
Cori Daines
(C)
Isaac Deaton
(I)
Alexandria Evans
(A)
Paige Field
(P)
Dave Francisco
(D)
Annette T Hastie
(AT)
Bob Hmieleski
(B)
Jeffrey O Krings
(JO)
Yanqin Liu
(Y)
Janell L Merchen
(JL)
Deborah A Meyers
(DA)
Nirushan Narendran
(N)
Stephen P Peters
(SP)
Anna Pippins
(A)
Matthew A Rank
(MA)
Ronald Schunk
(R)
Raymond Skeps
(R)
Benjamin Wright
(B)
Tina M Banzon
(TM)
Lisa M Bartnikas
(LM)
Sachin N Baxi
(SN)
Vishwanath Betapudi
(V)
Isabelle Brick
(I)
Conor Brockway
(C)
Thomas B Casale
(TB)
Kathleen Castillo-Ruano
(K)
Maria Angeles Cinelli
(MA)
Elena Crestani
(E)
Amparito Cunningham
(A)
Megan Day-Lewis
(M)
Natalie Diaz-Cabrera
(N)
Angela DiMango
(A)
Brittany Esty
(B)
Eva Fandozzi
(E)
Jesse Fernandez
(J)
Elizabeth Fitzpatrick
(E)
Victoria E Forth
(VE)
Katarina Gentile
(K)
David Gubernick
(D)
Seyni Gueye-Ndiaye
(S)
Sigfus Gunnlaagsson
(S)
Marissa Hauptmann
(M)
Stephanie N Hudey
(SN)
Donya S Imanirad
(DS)
Tiffani Kaage
(T)
Nicholas Kolinsky
(N)
Brenna LaBere
(B)
Peggy Sue Lai
(PS)
Meghan Le
(M)
Dennis K Ledford
(DK)
Richard Lockey
(R)
Margee Louisias
(M)
Andrew J Macginnitie
(AJ)
Michelle C Maciag
(MC)
Allison O'Neill
(A)
Amber N Pepper
(AN)
Perdita Permaul
(P)
Mya Pugh
(M)
Dianna Queheillalt
(D)
Tarnjot Saroya
(T)
William Sheehan
(W)
Catherine Smith
(C)
Carmela Socolovsky
(C)
Else Treffeisen
(E)
Lorenzo Trippa
(L)
Abigail Tulchinsky
(A)
Christina Yee
(C)
Tina Carter
(T)
Jun Fu
(J)
Vanessa Garcia
(V)
Jenny Hixon
(J)
Carly Jackson
(C)
Yuan Ji
(Y)
Ravi Kalhan
(R)
Opinderjit Kaur
(O)
Grace Li
(G)
Melanie M Makhija
(MM)
Spring Maleckar
(S)
Edward T Naureckas
(ET)
Anju T Peters
(AT)
Valerie Press
(V)
Mehreen Qureshi
(M)
Paul A Reyfman
(PA)
Sharon R Rosenberg
(SR)
Dominika Ryba
(D)
Jianrong Sheng
(J)
Ben Xu
(B)
Rafeul Alam
(R)
Darci Anderson
(D)
Sonya Belimezova
(S)
Jennifer Bitzan
(J)
Geoffrey Chupp
(G)
Brian J Clark
(BJ)
Lauren Cohn
(L)
Margaret Hope Cruse
(MH)
Jean Estrom
(J)
Leah Freid
(L)
Jose Gomez Villalobos
(JG)
Nicole Grant
(N)
Vamsi P Guntur
(VP)
Carole Holm
(C)
Christena Kolakowski
(C)
Laurie A Manka
(LA)
Naomi Miyazawa
(N)
Juno Pak
(J)
Diana M Pruitt
(DM)
Sunita Sharma
(S)
Allen D Stevens
(AD)
Kisori Thomas
(K)
Brooke Tippin
(B)
Karissa Valente
(K)
Cynthia L Wainscoat
(CL)
Michael P White
(MP)
Daniel Winnica
(D)
Shuyu Ye
(S)
Pamela L Zeitlin
(PL)
Julia Bach
(J)
Joshua Brownell
(J)
Lauren Castro
(L)
Julie DeLisa
(J)
Sean B Fain
(SB)
Paul S Fichtinger
(PS)
Heather Floerke
(H)
James E Gern
(JE)
Vinay Goswamy
(V)
Jenelle Grogan
(J)
Wendy Hasse
(W)
Rick L Kelley
(RL)
Danika Klaus
(D)
Stephanie LaBedz
(S)
Paige Lowell
(P)
Andrew Maddox
(A)
Sameer K Mathur
(SK)
Amanda McIntyre
(A)
Lourdes M Norwick
(LM)
Sharmilee M Nyenhuis
(SM)
Matthew J O'Brien
(MJ)
Tina Palas
(T)
Andrea A Pappalardo
(AA)
Mark Potter
(M)
Sima K Ramratnam
(SK)
Daniel L Rosenberg
(DL)
Eric M Schauberger
(EM)
Mark L Schiebler
(ML)
Angela Schraml
(A)
Ronald L Sorkness
(RL)
Mohamed Taki
(M)
Matthew C Tattersall
(MC)
Jissell Torres
(J)
Lori Wollet
(L)
Simon Abi-Saleh
(S)
Lisa Bendy
(L)
Larry Borish
(L)
James F Chmiel
(JF)
Aska Dix
(A)
Lisa France
(L)
Rebecca Gammell
(R)
Adam Gluvna
(A)
Brittany Hirth
(B)
Bo Hu
(B)
Elise Hyser
(E)
Kirsten M Kloepfer
(KM)
Michelle Koo
(M)
Nadia L Krupp
(NL)
Monica Labadia
(M)
Joy Lawrence
(J)
Laurie Logan
(L)
Angela Marko
(A)
Brittany Matuska
(B)
Deborah Murphy
(D)
Rachel Owensby
(R)
Erica A Roesch
(EA)
Don B Sanders
(DB)
Jackie Sharp
(J)
W Gerald Teague
(WG)
Laura Veri
(L)
Kristin Wavell Shifflett
(KW)
Matt Camiolo
(M)
Sarah Collins
(S)
Jessa Demas
(J)
Courtney Elvin
(C)
Marc C Gauthier
(MC)
Melissa Ilnicki
(M)
Jenn Ingram
(J)
Lisa Lane
(L)
Seyed Mehdi Nouraie
(SM)
John B Trudeau
(JB)
Michael Zhang
(M)
Jeffrey Barry
(J)
Howard Brickner
(H)
Janelle Celso
(J)
Matejka Cernelc-Kohan
(M)
Damaris Diaz
(D)
Ashley Du
(A)
Sonia Jain
(S)
Neiman Liu
(N)
Yusife Nazir
(Y)
Julie Ryu
(J)
Pandurangan Vijayanand
(P)
Rogelio Almario
(R)
Ariana Baum
(A)
Kellen Brown
(K)
Marilynn H Chan
(MH)
Barbara Gale
(B)
Angela Haczku
(A)
Richart W Harper
(RW)
Raymond Heromin
(R)
Celeste Kivler
(C)
Brooks T Kuhn
(BT)
Ngoc P Ly
(NP)
Paula McCourt
(P)
Xavier Orain
(X)
Audrey Plough
(A)
Karla Ramirez
(K)
Ellese Roberts
(E)
Michael Schivo
(M)
Amisha Singapuri
(A)
Catherine Smith
(C)
Tina Tham
(T)
Daniel Tompkins
(D)
Patricia Michelle Twitmyer
(PM)
Jade Vi
(J)
Jarron Atha
(J)
Jennifer Bedard
(J)
Jonathan S Boomer
(JS)
Andrew Chung
(A)
Vanessa Curtis
(V)
Chase S Hall
(CS)
Emily Hart
(E)
Fatima Jackson
(F)
Pamela Kemp
(P)
Sharli Maxwell
(S)
Maggie Messplay
(M)
Crystal Ramirez
(C)
Brynne Thompson
(B)
Ashley Britt
(A)
Hope Bryan
(H)
Nathan M Gotman
(NM)
Yue Jiang
(Y)
Michael R Kosorok
(MR)
David T Mauger
(DT)
Kelsey Meekins
(K)
Jeanette K Mollenhauer
(JK)
Sarah Moody
(S)
Cheyanne Ritz
(C)
Stefanie Schwartz
(S)
Chalmer Thomlinson
(C)
Nicole Wilson
(N)
Commentaires et corrections
Type : ErratumIn
Informations de copyright
Copyright © 2021 The Authors. Published by Elsevier Inc. All rights reserved.
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